MAUDE Adverse Event Report: BIOMET MICROFIXATION STERNALOCK 360 MULTI-IMPLANT SYSTEM; PLATE, FIXATION, BONE

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Impaired Healing (2378)
Date of Event	02/04/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).The device will not be returned for analysis as it was discarded; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2021-00086.Medical products: unknown sternalock screw, part# ni, lot# ni.
Event or Problem Description
It was reported the patient underwent a revision to remove sternal closure device six (6) months following implantation due to infection.It was suggested that the patient condition of diabetes may have contributed to the delayed healing of an infection.It was indicated the 8 hole x plate component was implanted on the manubrium instead of the body of the sternum as recommended in the ifu.Attempts have been made and no further information is available.
Additional Manufacturer Narrative
Upon further review, the root cause of the reported event was determined to be unrelated to the implanted zimmer biomet device and therefore not reportable.The patient developed an infection and product was explanted approximately 5 1/2 months after implant.It was noted the patient had diabetes which is known to impact a patient's ability to heal and may contribute to development of an infection.During the investigation process a review of the sterile certifications for sl360 multi-implant system were reviewed and found to be conforming with no applicable deviations.Devices were verified to have gone through acceptable sterilization process following iso/aami/astm & eu published guidelines.As there are no indications of a product or process issues identified affecting implant safety or effectiveness, therefore implanted product are not identified as the source or contributing to the reported infection.There are multiple factors that may contribute to an infection that are outside the control of zimmer biomet, such as external factors, i.E.Hospital/surgical environment, provider related risk factors, and/or patient comorbidities such as risk factors.In this case, information received indicates the patient has diabetes which is a known risk factor which can lead to slow or impaired healing, and predisposition to infection.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: STERNALOCK 360 MULTI-IMPLANT SYSTEM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11368654
• Report Number: 0001032347-2021-00085
• Device Sequence Number: 11597066
• Product Code: HRS
• UDI-Device Identifier: 00841036190668
• UDI-Public: (01)00841036190668(17)250330(10)066030
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K151019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 74-0004
• Device Lot Number: 066030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/03/2021
• Supplement Date Received by Manufacturer: 05/14/2021
• Initial Report FDA Received Date: 02/23/2021
• Supplement Report FDA Received Date: 05/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Weight: 86